An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adoles… (NCT07762313) | Clinical Trial Compass
Not Yet RecruitingPhase 3
An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.
10 participantsStarted 2026-09
Plain-language summary
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available.
The main questions the study aims to answer are:
Safety and tolerability of Symvess in adolescent patients? Determine patency of Symvess over 12-months Evaluate the long-term amputation-free rate Determine the ability of Symvess to remain infection-free
Participants will undergo implantation of Symvess to repair an arterial injury in an extremity using standard surgical techniques. Following implantation, patients will be followed for up to 12-months where they will undergo standard safety assessments, patency assessments using Duplex Ultrasound, and examination of the surgical site.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator
. Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss
. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm SYMVESS per the judgment of the treating surgeon, taking into account vasoconstriction and situational inflow and outflow considerations
. Autologous vein graft is either not feasible, in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit) or is not desirable because of the urgency of revascularization
. Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-Related Adverse Events
. Patient is able and willing to provide informed assent and parent (or legal representative) is able and willing to provide informed consent prior to treatment with SYMVESS
. Life expectancy of at least 1 year based on clinical assessment by the Investigator
Exclusion criteria
. Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7
. Injury Severity Score (ISS) \>60
. Known pregnant females
. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS
. Previous exposure to SYMVESS
. Known participation in any investigational study within the last 30 days
. Employees of the sponsor or patients who are employees or relatives of the Investigator